MRIGlobal Bioengagement Group, Frederick, Maryland

INTERNATIONAL BSL-3 LABORATORY TRAINING PROGRAM SUPPORT SHINIAN (STONE) CAO, MD, CBSP; LOLLY GARDINER, MBA, RBP, CBSP, SM (NRCM); ALEX HAMILL, PH.D., SCPM, PMP

Communicable diseases and emerging infectious diseases threaten global public health.

One of the major means of addressing the concerns about communicable diseases in both industrialized and less-developed countries is through the development of strong surveillance systems.

Introduction

Introduction

Global laboratory services are the essential elements of these surveillance systems. Development of global laboratory capacities BSL-2/3 and ABSL-2/3 laboratories Global laboratory networks—WHO, CDC, and

OIE (World Organization for Animal Health)

Example: BSL-3 Laboratory Capabilities Contribute to Global Disease Surveillance

Middle East Respiratory Syndrome

New Avian Influenza A (H7N9) Virus in China

Highly Pathogenic Avian Influenza A (H5N1)

Severe Acute Respiratory Syndrome (SARS)

Example: Improving Global Capacities for Infectious Disease Surveillance and Detection

Major zoonotic events over the past 72 years

Disproportionate numbers/distribution

Improvement

BSL-3/ABSL-3 Laboratories Around the World Involved in Surveillance Activities

Examples: Thailand, Indonesia, Myanmar, Bangladesh, China, and

India Kenya, South Africa, and Nigeria Kazakhstan and Georgia

Challenges to Effective Surveillance: BSL-3 Training in Less-Developed Countries

Challenges faced by these countries that impact effectiveness and safety: Lack of training and skills needed to safely operate

BSL-3 facilities according to international guidelines Local regulations vs. international guidelines Lack of, outdated, and contradictory

BSL-3 Training in Less-Developed Countries

Local regulations vs. international guidelines Example: Pathogen-based laboratory safety requirement

Personal Protective Equipment (PPE) requirement Ultraviolet light requirement

Inexperience in biorisk-based laboratory management Biorisk assessment and management

Lack of more in-depth, sustainable training linked to areas of professional responsibility

Limited resources Qualified and experienced trainers to provide training To focus on biosafety professional and career development

Unstable job market High turnover rate

BSL-3 Training in Less-Developed Countries

BSL-3 Training in Less-Developed Countries

Solutions to these challenges: Provide innovative and easily accessible training More targeted training (country-facility and worker-

specific) provided by international funding agencies

and training providers Establishing sustainable local training program

supported by local government and international funding agencies

BSL-3 Training in Less-Developed Countries

Solutions to these challenges: Professional development Biosafety officer, BSL-3 laboratory

manager, biosecurity specialist

Buy-in Government, organization, and institute

International BSL-3 training program must be cost-effective

International BSL-3 Training—MRIGlobal Approach

Staff Training

Mentorship

Local National

Biosafety Programs

BSL-3 Laboratory—Staff Training

Refresher

Hands-on

Initial

• Location: BSL-3 laboratory • Provided by MRIGlobal with

local national trainers

• Location: BSL-3 laboratory • Provided by MRIGlobal with

local national support

• Location: BSL-2 or BSL-3 mock laboratory

• Provided by MRIGlobal trainers

Staff Training

Time

International mentorship Not just a train-the-trainer program Professional development program Start from pre-existing local biosafety

training/education programs Existing public health and education systems Local laboratory, hospital, university/institute

BSL-3 Training—Mentoring Program

International mentorship Fellows from the program will acquire the knowledge

and skills: Provide technical recommendations/solutions to government

agencies, laboratory managers and international collaborators according to local and international regulations

BSL-3 Training—Mentoring Program

Fellows from the program will acquire the knowledge and skills to: Develop and implement a facility-specific BSL-3 biosafety/

biosecurity training program Conduct training Perform training evaluation and improvement

BSL-3 Training—Mentoring Program

Pre-existing

local program

Core curriculum

Staff training program

Mentor core curriculum delivery Long-distance learning Mentoring at MRIGlobal BSL-3 facilities Publication and presentation

Improve pre-existing local biosafety regulations/programs or establish a program

Support/provide staff training

Major Mentoring Activities

Activity Highlights

Staff Training and Mentorship Timeline

Staff training

Mentorship

Initial Hands-on Refresher

Mentorship

Preparation

Key Steps in Training Program Development

Training needs assessment Information collection Facility features and involved biological activities Regulations/guidelines and (biosafety) training programs Safety culture

Communication with stakeholders Government agencies, laboratory directors, funding

organizations, contractors, and others

Program development and finalization Training outcome evaluation

knowledge, skills, and performance

Key Steps in Training Program Development

Knowledge, Skills, and Performance Areas

• Biosafety/biosecurity regulations and guidelines: WHO Laboratory Biosafety Manual/CEN Workshop Agreement/CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)

• Biological risk assessment • Document development: Biosafety manual and Standard

Operating Procedures (SOP)

Example: Mentoring Program Evaluation

Knowledge, Skills, and Performance

• Training: Design, material preparation, training, evaluation, improvement, and documentation

• Improving local biosafety/biosecurity programs: Management, problem solving, and communication

• Promoting biosafety/biosecurity awareness: Public speech, publication, and presentation

Example: Mentoring Program Evaluation

Evaluation Methods

• Observation • Interview • Examination • Document review

Example: Mentoring Program Evaluation

Continuous Improvement and Monitoring System

Local Biosafety

Improvement

All Staff Training

Training Preparation and Support

Feedback Information Collection and Analysis

Improvement Through Mentoring

Program

The international BSL-3 training program provides: Facility-specific, cost-effective, and sustainable

capacity-building solutions for research and diagnostic laboratory facilities throughout the world

Results of Successful Engagements

Comprehensive approach provides initial and refresher training concurrent with development of local training capability within the existing public health and education systems.

Strategic approach results in sustainable, regionally appropriate local capacity to independently provide laboratory training and technical solutions for international facilities.

Results of Successful Engagements

Lolly Gardiner, MBA, SM (NRCM), RBP, CBSP and Alex Hamill, Ph.D., SCPM, PMP

Joanne Horn, Ph.D. and Kenneth Yeh MRIGlobal Bioengagement Group

Stacy Agar, Sharon Altmann, Charles Buck, Donald Burgess, Debanjana Dasgupta, Beverly van den Heuvel, Jolanta Jacobs, Konrad Juszkiewicz, Ray Lenhoff, Oxana Mazurova, Barbara Rinehart, Casey Ross, Tad Simons, Paul D. Stamper, Kirk Wilhelm, Robyn Woodbury

Acknowledgements

scao@mriglobal.org